HIV-1 InfectionPhase 4NCT00556634
Incidence and Severity of Neuropsychiatric Adverse Events of Efavirenz Given as a Stepped Dosage vs. the Usual Dosage
A Phase 4 study testing Efavirenz in people with HIV-1 Infection and HIV Infection, run by Sociedad Andaluza de Enfermedades Infecciosas at 10 sites in Spain.
Trial summary
Background: Neuropsychiatric side effects (NPSEs) occur in a significant proportion of subjects after initiation of efavirenz (EFV) and may limit its use in certain patients. Objectives: To evaluate the incidence and severity of NPSEs and antiviral efficacy of EFV given as a stepped dosage over 2 weeks versus the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1 Infection, HIV Infection
- What is being tested?
- Efavirenz
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 10 sitesSpain
- Study dates
- Apr 2006to Jan 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age older than 18 years
- HIV-1 infection
- Women of child-bearing age: negative pregnancy test
- Ability to understand and sign a written consent form
Who cannot join
- Pregnancy..
- Illegal drug or methadone use.
- Major psychiatric disease antecedents or starting new psychotropic agents in the last 4 weeks
- Concomitant treatment with rifamycins, protease inhibitors or drugs which interfere the pharmacokinetic of efavirenz.
- Hepatic insufficiency
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Spain10 sites
Hospital Torrecardenas
Almería, Almeria
Hospital Universitario Puerta del Mar
Cadiz, Cadiz
Hospital Universitario Reina Sofía
Córdoba, Cordoba
Hospital Juan Ramon Jimenez
Huelva, Huelva
Hospital de Jerez
Jerez de la Frontera, Cadiz
Hospital Universitario Carlos Haya
Málaga, Malaga
Hospital Universitario Virgen de la Victoria
Málaga, Malaga
Hospitales Universitarios Virgen del Rocio
Seville, Seville, 41013
Hospital Universitario de Valme
Seville, Seville
Hospital Universitario Virgen Macarena
Seville, Seville
About this study
Official title: Randomized, Double-Blinded Clinical Trial to Evaluate the Incidence and Severity of Neuropsychiatric Side Effects and Antiviral Efficacy of Efavirenz Given as a Stepped Dosage Over 2 Weeks Versus the Usual Dosage in HIV-Infected Patients.
Background: Neuropsychiatric side effects (NPSEs) occur in a significant proportion of subjects after initiation of efavirenz (EFV) and may limit its use in certain patients.
Objectives: To evaluate the incidence and severity of NPSEs and antiviral efficacy of EFV given as a stepped dosage over 2 weeks versus the usual dosage.
Read more
Methods: Randomized, double blind, multicentric clinical trial in which a progressive dosage (arm A: 200 mg qd for 6 days, 400 mg qd for 7 days and 600 mg qd from day 14 forward) was compared with conventional administration (arm B: 600 mg qd from the first day). All patients received additional treatment with 2 NRTIs.
The incidence and intensity of NPSEs and sleep disorders were assessed using a Likert-type scale specifically designed. Efficacy was assessed by percent of virological failures.
- Conditions
- HIV-1 Infection, HIV Infection
- Being tested
- Efavirenz
- Keywords
- HIV, efavirenz, central nervous system, adverse effects
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EfavirenzDrug
Efavirenz given in a stepped dosage over 2 weeks (200 mg qd for 6 days plus placebo, 400 mg qd for 7 days plus placebo and 600 mg qd from day 14 forward)
OR
Efavirenz usual dosage (600 mg/day from the first day)
| Study group | Role | What they receive |
|---|---|---|
| B | Active comparator | Not described Receives: Drug: Efavirenz |
| A | Experimental | Not described Receives: Drug: Efavirenz |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence and severity of neuropsychiatric side effects
Measured: 4 weeks
Secondary outcomes (1)
Virological efficacy
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2007 (estimated)
- Study startApr 2006
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sociedad Andaluza de Enfermedades Infecciosas
- Sponsor type
- Research network
- Collaborators
- Junta de Andalucia
- Investigators
- Luis F Lopez-Cortes, MD, PhD, Study director, Hospitales Universitarios Virgen del Rocio. Seville. Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00556634
- Sponsor's protocol ID
- SAEI_EFV
- Status last verified
- Jan 2009
- First submitted
- 8 Nov 2007
- Last updated
- 15 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gutierrez-Valencia A, Viciana P, Palacios R, Ruiz-Valderas R, Lozano F, Terron A, Rivero A, Lopez-Cortes LF; Sociedad Andaluza de Enfermedades Infecciosas. Stepped-dose versus full-dose efavirenz for HIV infection and neuropsychiatric adverse events: a randomized trial. Ann Intern Med. 2009 Aug 4;151(3):149-56. doi: 10.7326/0003-4819-151-3-200908040-00127. Epub 2009 Jul 6.
PubMed 19581631
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blinded Clinical Trial to Evaluate the Incidence and Severity of Neuropsychiatric Side Effects and Antiviral Efficacy of Efavirenz Given as a Stepped Dosage Over 2 Weeks Versus the Usual Dosage in HIV-Infected Patients.
- ClinicalTrials.gov ID
- NCT00556634
- Acronym / sponsor ID
- SAEI_EFV
- Conditions
- HIV-1 Infection, HIV Infection
- Keywords
- HIV, efavirenz, central nervous system, adverse effects
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Sociedad Andaluza de Enfermedades InfecciosasResearch network
- Collaborators
- Junta de Andalucia
- Study start
- Apr 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 12 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Neuropsychiatric side effects (NPSEs) occur in a significant proportion of subjects after initiation of efavirenz (EFV) and may limit its use in certain patients.
Objectives: To evaluate the incidence and severity of NPSEs and antiviral efficacy of EFV given as a stepped dosage over 2 weeks versus the usual dosage.
Methods: Randomized, double blind, multicentric clinical trial in which a progressive dosage (arm A: 200 mg qd for 6 days, 400 mg qd for 7 days and 600 mg qd from day 14 forward) was compared with conventional administration (arm B: 600 mg qd from the first day). All patients received additional treatment with 2 NRTIs.
The incidence and intensity of NPSEs and sleep disorders were assessed using a Likert-type scale specifically designed. Efficacy was assessed by percent of virological failures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B | Active comparator | Drug: Efavirenz |
| A | Experimental | Drug: Efavirenz |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age older than 18 years
- HIV-1 infection
- Women of child-bearing age: negative pregnancy test
- Ability to understand and sign a written consent form
Key exclusion criteria (5 listed)
- Pregnancy..
- Illegal drug or methadone use.
- Major psychiatric disease antecedents or starting new psychotropic agents in the last 4 weeks
- Concomitant treatment with rifamycins, protease inhibitors or drugs which interfere the pharmacokinetic of efavirenz.
- Hepatic insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EfavirenzEfavirenz given in a stepped dosage over 2 weeks (200 mg qd for 6 days plus placebo, 400 mg qd for 7 days plus placebo and 600 mg qd from day 14 forward) OR Efavirenz usual dosage (600 mg/day from the first day) | Drug | A, B |
Primary outcome
incidence and severity of neuropsychiatric side effects
Time frame: 4 weeks
1 secondary outcome
Virological efficacy
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2009.
- Derived from this study: PubMed 19581631Gutierrez-Valencia A, Viciana P, Palacios R, Ruiz-Valderas R, Lozano F, Terron A, Rivero A, Lopez-Cortes LF; Sociedad Andaluza de Enfermedades Infecciosas. Stepped-dose versus full-dose efavirenz for HIV infection and neuropsychiatric adverse events: a randomized trial. Ann Intern Med. 2009 Aug 4;151(3):149-56. doi: 10.7326/0003-4819-151-3-200908040-00127. Epub 2009 Jul 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis F Lopez-Cortes, MD, PhD study director
Hospitales Universitarios Virgen del Rocio. Seville. Spain
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Efavirenz in people with HIV-1 Infection and HIV Infection, run by Sociedad Andaluza de Enfermedades Infecciosas at 10 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence and severity of neuropsychiatric side effects (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00556634, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2009.